Servier's Tibsovo accepted for FDA priority review in MDS

The US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for French privately-held drugmaker Servier’s Tibsovo (ivosidenib tablets) in the treatment of patients with isocitrate dehydrogenase 1 (IDH1)-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS).

If approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within this molecularly defined subset., the company noted.

The FDA approved Tibsovo for the treatment of patients with newly diagnosed IDH1-mutated acute myeloid leukemia (AML) in adults 75 years or older, in May last year. In 2021, Tibsovo won approval for cholangiocarcinoma, a rare and aggressive form of cancer.